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Opportunity: Senior BIOSTATISTICIAN--NJ (US)
Submitted by Mike Wilmarth; posted on Saturday, September 06, 2003
A client of ours in Parsippany, NJ is pleased to announce an opportunity for a Senior Biostatistician in the Biostatistics Department. They are a biopharmaceutical company focused on the development of novel therapeutics for the treatment of hyperparathyroidism, osteoporosis, g.i. disorders, stroke, pain and other debilitating diseases and disorders. Benefits offered include stock option grants, participation in employee stock purchase plan, full medical and dental benefits beginning on the first day of employment, subsidized child care, as well as a 401(k) and flexible benefits plan.
This position is responsible for the management of statistical activities within the Biostatistics department, including oversight of all statistical tasks performed within or for the Biostatistics department. This position reports to the Senior Director, Biostatistics.
POSITION CRITERIA:
- Develop, implement and document statistics objectives that meet the goals set by the Senior Director, Biostatistics
- Evaluate and recommend statistical procedures and software for use within the Biostatistics department
- Manage departmental statistical activities, including writing SOPs, writing work instructions for performing statistical activities, training users on these activities, and establishing and prioritizing time lines and tasks for statistics deliverables
- Develop, implement and document statistical activities that meet the overall statistics strategy, including standardized sections of protocols and reports, a standardized statistical analysis plan, standardized shells for tables, figures and listings, a standardized database structure and standardized programs (including SAS macros) that meet the specifications of the FDA and other regulatory agencies
- Provide supervision, technical guidance and mentoring to statisticians
- Manage and/or perform study related statistical activities, using standardized programs where possible
- Prepare, QC, document, maintain and archive statistical procedures and programs
- Review development plans
- Estimate sample sizes for studies, determine appropriate statistical procedures, write statistics sections of protocol, review protocol, write statistical analysis plan, and co-write/review report and publications, maintaining consistency within a project and, where possible, across projects
- Review study materials (e.g., CRF, monitoring conventions, data base specifications, edit checks) for conformance with protocol, standardized data base structure and standardized programs
- Write or review specifications for creating analysis datasets from raw datasets
- Assess data integrity and validity of data, including review of edit checks
- Write or review protocol deviations specifications
- Perform planned and ad hoc statistical analyses and review and approve results presented in tables, figures and listings and conclusions for reports, labeling, publications
- Review SAS output (tables, figures and listings), data sets and programs for submission to regulatory agencies
- Represent statistics at regulatory meetings
REQUIREMENTS
- Ph.D and at least 2 years of relevant experience, MS and at least 10 years of relevant experience, or BS and at least 15 years of relevant experience.
What do you think? If you are interested in pursuing this opportunity and are authorized to work in the US, please forward to workwonders[at]cox.net:
- your resume in word or text format
- your salary requirement
It is important to use the position title as the subject of your email to enable your resume to reach the appropriate recruiter as quickly as possible.
Thank you for your time - have a great day!
Mike Wilmarth
mike[at]workwondersstaffing.net
http://www.workwondersstaffing.net
[Please reference Bioinformatics.Org when responding to this announcement.]
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